Pharmacovigilance

These include recognizing and reporting the side effects of a medicine, collecting and analysing them and preventing them with different arrangements. Doctors, pharmacists and other health professionals, authorities, furthermore manufacturers of medicinal products and distributors also take part in these activities. The role of manufacturers and distributors is to use the most up-to-date methods proposed by the authority and profession during non-clinical and clinical trials, to submit Summary of Product Characteristics providing the most safe use of medicinal products when applying for a Marketing Authorisation, to follow and register the reported side effects of their authorised medicinal product. Doctors' and health professionals' tasks are to recognize and report the side effects toward the competent health authority. During the process of marketing auhtorisation the safety is being followed with attention by the authority, the reported side effects are assessed, collected and registered after issuing the marketing authorisation, and if necessary the use of medicinal products are specified or limited in different ways by the authority.

Pharmacovigilance helps know more exact details about the safety profile of medicinal products through collecting and assessing the safety data available, therefore ensures the most effective and safe treatment of patients.

Successfulness of pharmacovigilance depends first of all on the consultant's active cooperation. They are the ones in the situation to take note of any suspicion of a side effect in their everyday practice, and report them to the Pharmacovigilance Department of the National Insitute of Pharmacy.

Besides the consultants there are other healthcare professionals (pharmacists, nurses) who may also experience supposed side effects during their work. It is important these side effects to be reported even if the healthcare professional is not sure about the relation between the applied medicine and the ocurred adverse effect.

If there would be any suspicion of an adverse effect please immediately prepare a report and contact a healthcare professional in charge or directly the Pharmacovigilance Department of the National Institute of Pharmacy.